Prospective Multi-Center Post Market Surveillance of the Efficacy and the Safety of the DuraSeal Dural Sealant System in a Craniotomy - Prospective Multi-Center Post Market Surveillance of the Efficacy and the Safety of the DuraSeal Dural Sealant System in a Craniotomy

Covidien Japan Inc.0 个研究点目标入组 140 人开始时间: 2012年1月26日最近更新: 2023年10月17日

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•1) Patient has active infection at surgical site. 2) Patient has impaired renal or hepatic function as diagnosed by Principal Investigator. 3) Patient has immune disorder. 4) Patient has traumatic injuries to the head. 5) Patient has dural gap exceeding 2mm. 6) Patient undergoing a contaminated cranial procedure that entails a dural incision involving perforation (other than superficial) of the sinus or mastoid air cells. 7) Patient undergoing procedures involving petrous bone drilling. 8) Patient surgery requires the use of non-autologous duraplasty materials. 9) Patient surgery requires DuraSeal application to confined bony structures where nerves are present. 10) Patient younger than 1 years of age, or in pregnant or breast feeding female. 11) Patient with a known allergy to FD&C Blue #1 dye. * All exclusion criteria are determined based on information contained in "Warnings" and "Contraindications" in the Instructions for Use.

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